I. Position Summary: Responsible for maintaining quality standards for Ocular's pharmaceutical and medical device products by managing activities associated with Supplier Quality Management, Document Control, Training, Internal Auditing, and Inspection Readiness. This is a critical position, and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the Sr. Director of Quality Systems and Compliance. II. Principal Duties and Responsibilities include the following: * Manage and maintain the following areas to drive improvements and achieve adherence with regulatory expectations: Supplier Quality Management, Audits, Documentation, Training, Inspection Readiness, and Quality Compliance. * Prepare the site for the success of internal and external audits ensuring that all the processes and systems remain aligned and in compliance with the applicable regulatory guidelines. * Coordinate vendor audits and manage the qualification of vendors supporting Ocular's GxP operations, including vendor selection and corresponding risk evaluation. * Collaborate in cross-functional scenarios for the onboarding of vendors, resolution of SCARs (Supplier Corrective Action Requests) and assessment of SCNs (Supplier Change Notifications). * Accomplish the objectives and goals of the Quality Organization. * Manage deviations, change controls, and CAPAs associated with the programs under responsibility, as * Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.) for gaps and improvements. * Adhere to all the policies and procedures as well as to the GxP guidelines driving the operations at OTX. * Identify opportunities for improvement and implement necessary actions to optimize the processes/systems and add efficiency to the Quality operations. * Participate in the implementation of new electronic systems, such as MasterControl. * Perform additional duties as deemed appropriate. III. Qualification Requirements: * Bachelor's * 10+ years of experience in the pharmaceutical industry. * Experience working in a GxP setting (commercial and clinical). * Expertise in vendors management, QMS, and compliance. * Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others. * Knowledge of electronic systems, such as MasterControl. * Experience with external regulatory inspections (e.g., FDA). * Excellent organizational skills and attention to * Strong interpersonal, verbal and written communication * Computer literacy, proficiency in MS Office, Excel, PowerPoint,